Sr Clinical Research Data Spec

Opening

Full Time 40 hours Range URG108 General Neurology Unit

Schedule

8 AM-4:30 PM

Responsibilities

GENERAL PURPOSE:

Works in partnership with the Infectious Disease Research Clinic to provide high quality, accurate data management support for complex studies. Coordinates with the investigational faculty, research clinic staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates, organizes, and articulates data entry plans to manage assigned caseloads and support less experienced staff. Acts as a Subject Matter Expert in data management. Mentors and provides guidance to others on the team. Maintains a working knowledge of parallel processes that are integrated with the function of clinical trial data and is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting. Develops, implements, and evaluates recruitment strategies, information, data, and study management systems. Assists PIs and research staff with recruitment efforts regarding industry sponsored, NIH, and Investigator Initiated studies.

RESPONSIBILITIES:

Data Management:

• Primarily responsible for creating, updating, and maintaining research data from charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures. Enters data accurately from Source documents (Paper or Electronic) into electronic case report forms on Study assigned databases.
• Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study. Manage high volumes and complex studies with minimal supervision.
• Partners with investigational faculty, sub-investigators and and research clinic staff, to coordinate and ensure data accuracy and provides data status reports, and ensure protocol data objectives are scheduled appropriately
• Able to answer a broad range of data clarifications (i.e. data queries) for each study, ranging from simple to complex.
• Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines; Ensure the integrity and security of study data.
• Meets with the staff to discuss trends/discrepancies in provided source documentation. Prepares data status update reports to be presented routinely at PI Oversight meetings.
• Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed following each monitoring visit.
• Assists with regulatory processes as needed and in support of Sr. Clinical Research Specialists and Clinic Manager

Quality Assurance/Management of Data:

• Partners with Quality Manager with the development and implementation of monitoring systems and methods to ensure quality, safety, efficiency, and consistency in processing human subject research data.
• Contributes to the design of the study protocol processes including assisting with the development and maintenance of standard operating procedures.
• Conducts quality checks and prepares documents for external monitoring visits.
• Communicates with sponsors when data correction is required.
• Monitoring and implementing change as needed throughout the study
• specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.

Subject Safety Reporting:

• Prepares source documentation logs (e.g., Adverse Events, Concomitant Medications, Medical History, Disease Response, etc.) for review by trial investigators by extracting this information from available source documents.
• Updates data and safety related information in OnCore (e.g., Serious Adverse Event reports), and collaborates with the trial investigators for review and submission to the applicable sponsor(s) and regulatory authorities.
• Develops reports and data clarifications (i.e. data queries) for each study. Under the guidance of the PI's and Research Nurses, answer more complex data clarifications (i.e., data queries) for each study.
• Ensures compliance in the reporting of subject adverse events (AE), medical events of special interest (MESI), and serious adverse events (SAE) and filing of these promptly to sponsors and IRBs.Recruitment:
• Independently performs chart review/pre-screening for eligibility and coordination of complex clinical research protocols.
• Assists in conducting quality checks for data accuracy with data source records as assigned. Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment.
• Partners and may lead in the development of methods and outcome reporting to improve and monitor the awareness and enrollment of volunteers in the IDRC trials. This includes assisting in the development of culturally relevant pamphlets, flyers, videos, and other recruitment and reporting tools to the target populations. Support relationships with community agencies and maintaining a presence in the community through attending relevant workshops and community activities.
• Keep consistently abreast of new innovative measures that are being used to recruit via multiple media sources, mobile devices, and social networks and report on its effectiveness. Maintain website and links with other sites to improve site's outreach capabilities.
• Develops, implements and evaluates recruitment strategies, information, data and reporting systems and study management systems.

Outreach:

• Contribute to team efforts in identifying key leaders in the community, create or foster opportunities to partner with local community-based organizations; church groups neighborhood agencies, businesses, etc. to increase awareness and to increase participation at the research site. Serve as a promotional recruiter for the VTEU/IDRC.
• Support programs to create interest and increase knowledge in the community around the research.
• Assist in developing workshops in conjunction with the IDRC staff to small groups of individuals, church groups, college organizations and community groups to explain the goals of the IDRC and increase awareness of the responsibilities and commitment of volunteers in a IDRC studies.
• Contribute to the development of activities to increase levels of "trust" in target populations to decrease barriers and ultimately increase participation in research studies. This may entail partnering with area organizations to provide a unified message to the community at major events or health fair etc.
• Facilitates and establishes community collaborations for major events. Develop and present reports detailing the effectiveness and outcomes of
• these strategies.

Other projects and job duties as assigned

QUALIFICATIONS:

• Bachelor's degree required.
• Master's degree preferred.
• And 2 year of relevant experience. Or equivalent combination of
• education and experience required.
• Skill in completing assignments accurately and with attention to detail required.
• Ability to understand and follow standard research protocols and procedures required.
• Ability to process and handle confidential information with discretion required.
• Commitment to the University's core values required.
• Ability to work independently and/or in a collaborative environment required.
• Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data required.
• Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
• Strong interpersonal, communication, and organizational skills required.
• Highly collaborative, works well in teams required.
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University's mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $51,810 - $72,534 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.